KR20220127843A - 단백질 치료제용 제형 - Google Patents

단백질 치료제용 제형 Download PDF

Info

Publication number
KR20220127843A
KR20220127843A KR1020227026642A KR20227026642A KR20220127843A KR 20220127843 A KR20220127843 A KR 20220127843A KR 1020227026642 A KR1020227026642 A KR 1020227026642A KR 20227026642 A KR20227026642 A KR 20227026642A KR 20220127843 A KR20220127843 A KR 20220127843A
Authority
KR
South Korea
Prior art keywords
composition
seq
binding domain
administered
day
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
KR1020227026642A
Other languages
English (en)
Korean (ko)
Inventor
조나단 클래퍼
데이비드 비엔베뉴
스콧 스트로맷
캐서린 제이. 맥마한
Original Assignee
압테보 리서치 앤드 디벨롭먼트 엘엘씨
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 압테보 리서치 앤드 디벨롭먼트 엘엘씨 filed Critical 압테보 리서치 앤드 디벨롭먼트 엘엘씨
Publication of KR20220127843A publication Critical patent/KR20220127843A/ko
Pending legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
KR1020227026642A 2020-01-13 2021-01-13 단백질 치료제용 제형 Pending KR20220127843A (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062960562P 2020-01-13 2020-01-13
US62/960,562 2020-01-13
US202063121633P 2020-12-04 2020-12-04
US63/121,633 2020-12-04
PCT/US2021/013294 WO2021146328A1 (en) 2020-01-13 2021-01-13 Formulations for protein therapeutics

Publications (1)

Publication Number Publication Date
KR20220127843A true KR20220127843A (ko) 2022-09-20

Family

ID=74592744

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227026642A Pending KR20220127843A (ko) 2020-01-13 2021-01-13 단백질 치료제용 제형

Country Status (11)

Country Link
US (1) US20230303720A1 (https=)
EP (1) EP4090367A1 (https=)
JP (2) JP2023512454A (https=)
KR (1) KR20220127843A (https=)
CN (1) CN115279406A (https=)
AU (1) AU2021207470A1 (https=)
BR (1) BR112022013725A2 (https=)
CA (1) CA3164385A1 (https=)
IL (1) IL294458A (https=)
MX (1) MX2022008654A (https=)
WO (1) WO2021146328A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109952112B (zh) 2016-09-21 2024-09-06 阿帕特夫研究和发展有限公司 Cd123结合蛋白和相关的组合物和方法
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
IL298999A (en) 2020-06-11 2023-02-01 Provention Bio Inc Methods and compositions for the prevention of type 1 diabetes
JP2024520444A (ja) 2021-05-24 2024-05-24 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を治療するための方法

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5283173A (en) 1990-01-24 1994-02-01 The Research Foundation Of State University Of New York System to detect protein-protein interactions
GB9518220D0 (en) 1995-09-06 1995-11-08 Medical Res Council Checkpoint gene
US6440418B1 (en) 1995-11-07 2002-08-27 Idec Pharmaceuticals Corporation Methods of treating autoimmune diseases with gp39-specific antibodies
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
JP2008501621A (ja) 2003-05-31 2008-01-24 マイクロメット アクツィエン ゲゼルシャフト Ｂ細胞関連疾患を処置するための二重特異性抗ｃｄ３、抗ｃｄ１９抗体構築物を含む薬学的組成物
DK1629011T3 (da) 2003-05-31 2010-05-03 Micromet Ag Humane anti-humane-DC3-bindingsmolekyler
MXPA06004035A (es) 2003-10-16 2006-08-31 Micromet Ag Aglutinantes cd3 de-inmunizados multi-especificos.
US7393662B2 (en) 2004-09-03 2008-07-01 Centocor, Inc. Human EPO mimetic hinge core mimetibodies, compositions, methods and uses
NZ573646A (en) 2006-06-12 2012-04-27 Wyeth Llc Single-chain multivalent binding proteins with effector function
TW200831129A (en) * 2006-10-06 2008-08-01 Amgen Inc Stable formulations
MX2009010611A (es) 2007-04-03 2010-03-26 Micromet Ag Enlazadores biespecificos, especificos para especies.
JP2011526792A (ja) 2008-07-02 2011-10-20 エマージェント プロダクト デベロップメント シアトル， エルエルシー ＴＮＦ−αアンタゴニスト多重標的結合性タンパク質
US20110293619A1 (en) 2008-10-01 2011-12-01 Micromet Ag CROSS-SPECIES-SPECIFIC PSMAxCD3 BISPECIFIC SINGLE CHAIN ANTIBODY
NO2344540T3 (https=) 2008-10-02 2018-04-28
US20130129723A1 (en) 2009-12-29 2013-05-23 Emergent Product Development Seattle, Llc Heterodimer Binding Proteins and Uses Thereof
CA2785907A1 (en) 2009-12-29 2011-07-28 Emergent Product Development Seattle, Llc Ron binding constructs and methods of use thereof
TWI653333B (zh) 2010-04-01 2019-03-11 安進研究（慕尼黑）有限責任公司 跨物種專一性之ＰＳＭＡｘＣＤ３雙專一性單鏈抗體
AU2011286024B2 (en) 2010-08-02 2014-08-07 Macrogenics, Inc. Covalent diabodies and uses thereof
KR102060389B1 (ko) 2011-05-21 2019-12-31 마크로제닉스, 인크. 사람 및 비-사람 cd3에 결합할 수 있는 cd3-결합 분자
JP6509724B2 (ja) 2012-04-20 2019-05-08 アプティーボ リサーチ アンド デベロップメント エルエルシー Ｃｄ３結合ポリペプチド
WO2016094873A2 (en) 2014-12-12 2016-06-16 Emergent Product Development Seattle, Llc Receptor tyrosine kinase-like orphan receptor 1 binding proteins and related compositions and methods
CN114181309B (zh) 2015-05-21 2024-07-30 鳄鱼生物科学公司 新型多肽
WO2017053469A2 (en) * 2015-09-21 2017-03-30 Aptevo Research And Development Llc Cd3 binding polypeptides
CN109952112B (zh) * 2016-09-21 2024-09-06 阿帕特夫研究和发展有限公司 Cd123结合蛋白和相关的组合物和方法
WO2019050521A1 (en) * 2017-09-07 2019-03-14 Macrogenics, Inc. DOSAGE SCHEMES OF BISPECIFIC DIACORPS CD123 X CD3 IN THE TREATMENT OF HEMATOLOGICAL MALIGNANCIES

Also Published As

Publication number Publication date
CA3164385A1 (en) 2021-07-22
US20230303720A1 (en) 2023-09-28
EP4090367A1 (en) 2022-11-23
MX2022008654A (es) 2022-08-18
JP2026021465A (ja) 2026-02-10
IL294458A (en) 2022-09-01
JP2023512454A (ja) 2023-03-27
CN115279406A (zh) 2022-11-01
WO2021146328A1 (en) 2021-07-22
AU2021207470A1 (en) 2022-07-07
BR112022013725A2 (pt) 2022-10-11

Similar Documents

Publication Publication Date Title
AU2019422629B2 (en) HEAVY-CHAIN ANTIBODIES (VHHs) AGAINST CLAUDIN 18A2 AND USE THEREOF
KR102559732B1 (ko) Cd123 결합 단백질 그리고 관련된 조성물 및 방법
KR102890653B1 (ko) 항-cd33 항체, 항-cd33/항-cd3 이중특이성 항체, 및 이의 용도
CN114181309B (zh) 新型多肽
KR101900953B1 (ko) Ｃｄ86 길항제 다중-표적 결합 단백질
DK2519543T3 (en) HETERODIMER BINDING PROTEINS AND USE THEREOF
KR101163240B1 (ko) 결합 구성체 및 이의 사용 방법
KR102355609B1 (ko) 다중 암 항원에 특이적으로 결합하는 삼중-특이적 결합 분자 및 그것의 사용 방법
AU2018304585B2 (en) Antigen binding proteins binding to 5T4 and 4-1BB and related compositions and methods
KR20220127843A (ko) 단백질 치료제용 제형
KR20180081532A (ko) 암 치료용 조성물 및 방법
JP2007528194A5 (https=)
KR20150139531A (ko) 이중특이적 이가 scFv-Ｆｃ 분자
KR20150122761A (ko) Ｔ 세포 활성화 항원 결합 분자
US20250215081A1 (en) Anti-cd19 agent and b cell targeting agent combination therapy for treating b cell malignancies
KR20240024819A (ko) 단백질 치료제의 투약 요법
KR20220140500A (ko) 약물 전달 시스템 성분에 대한 치료제 단백질의 흡착을 방지하기 위한 방법 및 조성물
CN118019762A (zh) 蛋白质治疗剂的给药方案
RU2804458C2 (ru) Антигенсвязывающие белки, связывающиеся с 5t4 и 4-1bb, и относящиеся к ним композиции и способы
KR20230117379A (ko) 이종이량체 psma 및 cd3-결합 이중특이적 항체
HK1243096A1 (en) Cd86 antagonist multi-target binding proteins

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

D21 Rejection of application intended

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D21-EXM-PE0902 (AS PROVIDED BY THE NATIONAL OFFICE)

PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: U-3-3-T10-T11-OTH-X000 (AS PROVIDED BY THE NATIONAL OFFICE)

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000